| CTRI Number |
CTRI/2021/03/031803 [Registered on: 08/03/2021] Trial Registered Prospectively |
| Last Modified On: |
31/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Mindfulness in Indian adults |
|
Scientific Title of Study
|
Effects of Mindfulness based intervention on mental well-being and quality of life in Indian adults: a randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANIRBAN PAL |
| Designation |
Consultant |
| Affiliation |
Apollo Gleneagles Medical centre |
| Address |
Department of Anaesthesiology and Pain Medicine, Apollo Gleneagles Medical Center, 48/1F Leela Roy Sarani
Kolkata
WEST BENGAL
700019
India |
| Phone |
09830761649 |
| Fax |
|
| Email |
pal.anirban1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANIRBAN PAL |
| Designation |
Consultant |
| Affiliation |
Apollo Gleneagles Medical centre |
| Address |
Department of Anaesthesiology and Pain Medicine, Apollo Gleneagles Medical Center, 48/1F Leela Roy Sarani
Kolkata
WEST BENGAL
700019
India |
| Phone |
09830761649 |
| Fax |
|
| Email |
pal.anirban1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANIRBAN PAL |
| Designation |
Consultant |
| Affiliation |
Apollo Gleneagles Medical centre |
| Address |
Department of Anaesthesiology and Pain Medicine, Apollo Gleneagles Medical Center, 48/1F Leela Roy Sarani
Kolkata
WEST BENGAL
700019
India |
| Phone |
09830761649 |
| Fax |
|
| Email |
pal.anirban1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ANIRBAN PAL |
| Address |
Department of Anaesthesiology and Pain Medicine, Apollo Gleneagles Medical Center, 48/1F Leela Roy Sarani, kolkata 19 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| anirban pal |
kalyani esi hospital |
west bengal
Kolkata
WEST BENGAL |
09830761649
pal.anirban1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kalyani ESI Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
no co-morbidites |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Face to face Mindfulness meditation |
An eight week meditation program |
| Comparator Agent |
wait-listed |
served as controls |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
apparently healthy adults |
|
| ExclusionCriteria |
| Details |
major co-morbidities |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
8 week Quality of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| qualitative data |
8 week qualitative data |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/03/2021 |
| Date of Study Completion (India) |
31/05/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Apparently healthy participants will be subjected to a 8 week mindfulness meditation program and effects on WHO Quality of life and mental well-being (by HADS score) will be compared with wait-listed controls, in this study. |